Application 208478

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE	No	No
002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 20MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208478-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL			2020-06-23
A208478-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL			2020-06-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`87673890dc5c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 13 · 258 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	fbd1c5da-67fb-4412-acb5-4d4c74a43654	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Macleods Pharmaceuticals Limited	7bd0f0ec-f7a3-4403-9a1a-11f18213631f	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	56a9e58f-567e-30cc-e063-6294a90a290f	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2e583569-499d-4f20-87ca-84e7d9868d22	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	52d8508b-aa98-cd89-5991-e2b5f982b6c6	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	303989c9-823e-4bcb-a7b3-7024fd0d3a38	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	2f76cd3b-fbfa-a193-e063-6294a90a1b32	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	e91c673d-c26c-4ff1-90d2-2b9d47a8d771	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	d57720ab-9f83-4da9-a57f-0d55e00a605c	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	1ea6235f-633c-af0b-e063-6294a90aad6d	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	606368de-dea3-4871-aa61-c00e77ed386f	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	bd26679f-f8ff-41d2-a384-bd1f66f8a614	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	6600f22e-d303-4fe3-8212-accd6fb06e62	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Unit Dose Solutions, Inc.	53c06fa9-ec26-5fa6-e063-6294a90a337f	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	8821431a-c387-4b75-9540-f92bd455e961	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Sun Pharmaceutical Industries Inc.	595ab888-6b55-4642-a32f-e8521821ed81	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	149322ec-9ee6-2223-e063-6294a90a8aac	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	52f99e39-fb92-e9f5-e063-6294a90a1b6a	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Coupler LLC	52561b3e-c20f-3536-e063-6394a90a6198	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM

Application 208478

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#